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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. BELIFU TENS UNIT STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE COUNTER

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SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. BELIFU TENS UNIT STIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE COUNTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Burn(s) (1757); Erythema (1840); Itching Sensation (1943); Pain (1994); Skin Irritation (2076)
Event Date 11/10/2020
Event Type  Injury  
Event Description
Reports has had sharp pains, skin irritation burns, itching, redness, for several days after using this device.
 
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Brand NameBELIFU TENS UNIT
Type of DeviceSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE COUNTER
Manufacturer (Section D)
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
MDR Report Key10837737
MDR Text Key216411736
Report NumberMW5097866
Device Sequence Number1
Product Code NUH
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/12/2020 Patient Sequence Number: 1
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